FastingNCT06543615
Preoperative Ultrasound Evaluation of Fasting Residual Gastric Volume in Patients With Previous Sleeve Gastrectomy
An observational study of Fasting, run by Ain Shams University at 1 site in Egypt.
Trial summary
Preoperative US assessment of residual gastric volume in both; patients with previous laparoscopic sleeve gastrectomy and those without history of bariatric surgeries, undergoing elective laparoscopic cholecystectomy, aiming to develop a step for recommendations for fasting guidelines Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Two groups both undergoing laparoscopic cholecystectomy the first group with history of laparoscopic sleeve gastrectomy, while the second group with No history of previous bariatric surgeries according to inclusion and exclusion criteria
Who may be able to join
- ASA (American Society of Anesthesiologists physical status classification) I-II
- Aged between 21 and 45 years old undergoing elective surgery.
- Fasting 8 hours preoperative.
- Body mass index less than 35 Kg/m2
Who cannot join
- ASA physical status more than II .
- Pregnant women.
- Patients above 45 years and below 21 years.
- History of drug intake of prokinetics or any drug that affect gastric emptying and/or motility.
- Diabetic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Ultrasound Evaluation of Fasting Residual Gastric Volume in Patients With Previous Sleeve Gastrectomy : Comparative Study With Patients Without History of Bariatric Surgeries
Preoperative US assessment of residual gastric volume in both; patients with previous laparoscopic sleeve gastrectomy and those without history of bariatric surgeries, undergoing elective laparoscopic cholecystectomy, aiming to develop a step for recommendations for fasting guidelines
Read the detailed description
No doubt, that perioperative aspiration of gastric content during anesthesia process is every anesthesiologist's nightmare, which can lead to serious morbidities and mortalities with a rate of 5% to 9 % in anesthesia airway management accidents.
Risk of aspiration usually present during induction of anesthesia due to passive regurgitation during endotracheal intubation while it may occur during recovery from anesthesia in patients with active vomiting.
It is known that the volume of residual gastric content is one of the most important factors that can lead to significant increase in the risk of perioperative pulmonary aspiration, acknowledging this fact, lead the American society of Anesthesiology (ASA) to recommend for eight hours fasting for solids (fats and/or meats), six hours for non-human milk and light meals, and two hours for clear fluids, to reduce residual gastric volume and subsequently the risk of perioperative aspiration.
There are many different ways to asses gastric content for example nasogastric tube aspiration of gastric content which is an invasive technique. Other ways include imaging tools like abdominal CT scan which is not easily done and will have extra cost on the patient . In addition, wireless motility capsules and gastric emptying scintigraphy can be used but all of them are not suitable for routine assessment.
On the other hand Point-of-Care (POC) ultrasound usage in anesthesia management has provided a wide range of rapid, bed side and non-invasive, easy and fast techniques that help to reduce the risk of morbidity and mortality. It also, helped to provide a technique for qualitative and quantitative assessments of residual gastric contents preoperatively through gastric antrum US assessment using measurement of the antral cross-sectional area.
In the past it was believed that gastric content more than 2.5 ml/kg was considered as an "at risk" stomach volume , but nowadays several studies using ultrasonography assessment of residual gastric content indicated that the accepted volume should be less than 1.5 ml/kg in healthy fasting adult to define an empty stomach.
It is well known that bariatric surgeries nowadays became very popular among patients suffering from obesity for the sake of better quality of life specially sleeve gastrectomy and Roux-en-Y gastric bypass surgeries. A statistical study was done among the American population in 2018 reported that about 252 000 bariatric procedures are being performed every year and the number is rising by time specially with advanced surgical techniques that reduced the complications of these types of surgeries. However; no statistics has been released for Egyptian population.
As regards, Nele, et. al. reported that gastric emptying was significantly reduced in patients with history of sleeve gastrectomy and Roux-en-Y gastric bypass surgeries as compared to obese patients by comparing gastric emptying scintigraphy, wireless motility capsule and gastrointestinal fluid aspiration techniques.
Also Eric, et al. in their meta-analysis study, have reported that gastric emptying time was reduced after gastric bypass surgery but it was constant or increased with endoscopically inserted intragastric balloons.
Many studies tried to asses changes in GIT physiology after bariatric surgeries including gastric emptying time using several methods as mentioned before but less frequently ultrasound guided assessment.
- Conditions
- Fasting
- Being tested
- Ultrasonography
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Ultrasound assessment of residual gastric volume
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing laparoscopic cholecystectomy with history of sleeve gastrectomy | Gastric residual volume will be assessed after 8 hours of fasting preoperatively using ultrasonography in patients undergoing laparoscopic cholecystectomy with history of sleeve gastrectomy Receives: Device: Ultrasonography | |
| Patients undergoing laparoscopic cholecystectomy with no history of bariatric surgeries | Gastric residual volume will be assessed after 8 hours of fasting preoperatively using ultrasonography in patients undergoing laparoscopic cholecystectomy with No history of bariatric surgeries Receives: Device: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual gastric volume
Measurement of residual gastric volume immediately preoperative in right lateral decubitus after fasting 8 hours
Measured: After fasting 8 hours immediately preoperative
Secondary outcomes (1)
incidence of aspiration
Documentation of aspiration incidence immediately preoperative, intraoperative or during recovery from anesthesia post operative
Measured: Perioperative ( immediately preoperative, intraoperative or during recovery from anesthesia post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543615
- Sponsor's protocol ID
- Fasting required preoperative
- Status last verified
- Nov 2024
- First submitted
- 5 Aug 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18.
PubMed 30443057Jia H, He E, Gao S, Hao W, Li Y, Liu W, Chen X, Jia Y, Wang Y. Ultrasound assessment of gastric contents and volume in patients undergoing endoscopic endonasal transsphenoidal surgery: a prospective observational study. Sci Rep. 2023 Feb 17;13(1):2848. doi: 10.1038/s41598-023-29893-2.
PubMed 36801927Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
PubMed 29624530Steenackers N, Vanuytsel T, Augustijns P, Deleus E, Deckers W, Deroose CM, Falony G, Lannoo M, Mertens A, Mols R, Vangoitsenhoven R, Wauters L, Van der Schueren B, Matthys C. Effect of sleeve gastrectomy and Roux-en-Y gastric bypass on gastrointestinal physiology. Eur J Pharm Biopharm. 2023 Feb;183:92-101. doi: 10.1016/j.ejpb.2022.12.018. Epub 2023 Jan 2.
PubMed 36603693
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasound Evaluation of Fasting Residual Gastric Volume in Patients With Previous Sleeve Gastrectomy : Comparative Study With Patients Without History of Bariatric Surgeries
- ClinicalTrials.gov ID
- NCT06543615
- Acronym / sponsor ID
- Fasting required preoperative
- Conditions
- Fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preoperative US assessment of residual gastric volume in both; patients with previous laparoscopic sleeve gastrectomy and those without history of bariatric surgeries, undergoing elective laparoscopic cholecystectomy, aiming to develop a step for recommendations for fasting guidelines
Detailed description
No doubt, that perioperative aspiration of gastric content during anesthesia process is every anesthesiologist's nightmare, which can lead to serious morbidities and mortalities with a rate of 5% to 9 % in anesthesia airway management accidents.
Risk of aspiration usually present during induction of anesthesia due to passive regurgitation during endotracheal intubation while it may occur during recovery from anesthesia in patients with active vomiting.
It is known that the volume of residual gastric content is one of the most important factors that can lead to significant increase in the risk of perioperative pulmonary aspiration, acknowledging this fact, lead the American society of Anesthesiology (ASA) to recommend for eight hours fasting for solids (fats and/or meats), six hours for non-human milk and light meals, and two hours for clear fluids, to reduce residual gastric volume and subsequently the risk of perioperative aspiration.
There are many different ways to asses gastric content for example nasogastric tube aspiration of gastric content which is an invasive technique. Other ways include imaging tools like abdominal CT scan which is not easily done and will have extra cost on the patient . In addition, wireless motility capsules and gastric emptying scintigraphy can be used but all of them are not suitable for routine assessment.
On the other hand Point-of-Care (POC) ultrasound usage in anesthesia management has provided a wide range of rapid, bed side and non-invasive, easy and fast techniques that help to reduce the risk of morbidity and mortality. It also, helped to provide a technique for qualitative and quantitative assessments of residual gastric contents preoperatively through gastric antrum US assessment using measurement of the antral cross-sectional area.
In the past it was believed that gastric content more than 2.5 ml/kg was considered as an "at risk" stomach volume , but nowadays several studies using ultrasonography assessment of residual gastric content indicated that the accepted volume should be less than 1.5 ml/kg in healthy fasting adult to define an empty stomach.
It is well known that bariatric surgeries nowadays became very popular among patients suffering from obesity for the sake of better quality of life specially sleeve gastrectomy and Roux-en-Y gastric bypass surgeries. A statistical study was done among the American population in 2018 reported that about 252 000 bariatric procedures are being performed every year and the number is rising by time specially with advanced surgical techniques that reduced the complications of these types of surgeries. However; no statistics has been released for Egyptian population.
As regards, Nele, et. al. reported that gastric emptying was significantly reduced in patients with history of sleeve gastrectomy and Roux-en-Y gastric bypass surgeries as compared to obese patients by comparing gastric emptying scintigraphy, wireless motility capsule and gastrointestinal fluid aspiration techniques.
Also Eric, et al. in their meta-analysis study, have reported that gastric emptying time was reduced after gastric bypass surgery but it was constant or increased with endoscopically inserted intragastric balloons.
Many studies tried to asses changes in GIT physiology after bariatric surgeries including gastric emptying time using several methods as mentioned before but less frequently ultrasound guided assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing laparoscopic cholecystectomy with history of sleeve gastrectomy | – | Device: UltrasonographyGastric residual volume will be assessed after 8 hours of fasting preoperatively using ultrasonography in patients undergoing laparoscopic cholecystectomy with history of sleeve gastrectomy |
| Patients undergoing laparoscopic cholecystectomy with no history of bariatric surgeries | – | Device: UltrasonographyGastric residual volume will be assessed after 8 hours of fasting preoperatively using ultrasonography in patients undergoing laparoscopic cholecystectomy with No history of bariatric surgeries |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Two groups both undergoing laparoscopic cholecystectomy the first group with history of laparoscopic sleeve gastrectomy, while the second group with No history of previous bariatric surgeries according to inclusion and exclusion criteria
Key inclusion criteria (4 listed)
- ASA (American Society of Anesthesiologists physical status classification) I-II
- Aged between 21 and 45 years old undergoing elective surgery.
- Fasting 8 hours preoperative.
- Body mass index less than 35 Kg/m2
Key exclusion criteria (5 listed)
- ASA physical status more than II .
- Pregnant women.
- Patients above 45 years and below 21 years.
- History of drug intake of prokinetics or any drug that affect gastric emptying and/or motility.
- Diabetic patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyUltrasound assessment of residual gastric volume | Device | Patients undergoing laparoscopic cholecystectomy with history of sleeve gastrectomy, Patients undergoing laparoscopic cholecystectomy with no history of bariatric surgeries |
Primary outcome
residual gastric volume
Time frame: After fasting 8 hours immediately preoperative
Measurement of residual gastric volume immediately preoperative in right lateral decubitus after fasting 8 hours
1 secondary outcome
incidence of aspiration
Time frame: Perioperative ( immediately preoperative, intraoperative or during recovery from anesthesia post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 30443057Sharma G, Jacob R, Mahankali S, Ravindra MN. Preoperative assessment of gastric contents and volume using bedside ultrasound in adult patients: A prospective, observational, correlation study. Indian J Anaesth. 2018 Oct;62(10):753-758. doi: 10.4103/ija.IJA_147_18.
- Background: PubMed 36801927Jia H, He E, Gao S, Hao W, Li Y, Liu W, Chen X, Jia Y, Wang Y. Ultrasound assessment of gastric contents and volume in patients undergoing endoscopic endonasal transsphenoidal surgery: a prospective observational study. Sci Rep. 2023 Feb 17;13(1):2848. doi: 10.1038/s41598-023-29893-2.
- Background: PubMed 29624530Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
- Background: PubMed 36603693Steenackers N, Vanuytsel T, Augustijns P, Deleus E, Deckers W, Deroose CM, Falony G, Lannoo M, Mertens A, Mols R, Vangoitsenhoven R, Wauters L, Van der Schueren B, Matthys C. Effect of sleeve gastrectomy and Roux-en-Y gastric bypass on gastrointestinal physiology. Eur J Pharm Biopharm. 2023 Feb;183:92-101. doi: 10.1016/j.ejpb.2022.12.018. Epub 2023 Jan 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual gastric volume (time frame: After fasting 8 hours immediately preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543615, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.